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Health Highlights: Feb. 26, 2021

Single Dose of Pfizer COVID Vaccine Highly Effective in Previously Infected People A single dose of the Pfizer COVID-19 vaccine provides strong protection...

Education Level Now Prime Driver of COVID Vaccine Hesitancy: Poll

FRIDAY, Feb. 26, 2021 -- In the early weeks of the U.S. vaccine rollout, race looked like it would determine who was willing to get a shot in the arm, but...

AHA News: From Mild COVID-19 to Heart Failure in 4 Weeks – at Age 20

FRIDAY, Feb. 26, 2021 (American Heart Association News) -- Madeline Neville tried her best to avoid catching COVID-19 while attending Temple University in...

Cutaneous Findings Described for Children With MIS-C

FRIDAY, Feb. 26, 2021 -- In a research letter published online Feb. 16 in Open Forum Infectious Diseases, cutaneous findings are described for multisystem...

Model Estimates Harm Attributed to Menthol Cigarettes

FRIDAY, Feb. 26, 2021 -- Menthol cigarettes have slowed the decline in smoking prevalence in the United States and have been responsible for 10.1 million extra...

Inappropriate Antibiotic Prescribing Common for Women With UTIs

FRIDAY, Feb. 26, 2021 -- A considerable proportion of women with uncomplicated urinary tract infection (UTI) have inappropriate antibiotic prescribing, and...

Decline in U.S. Suicide Rates From 2018 to 2019 Not Uniform

FRIDAY, Feb. 26, 2021 -- The rate of suicide declined overall from 2018 to 2019 in the United States, with significant declines observed in five states and...

Possible SARS-CoV-2 Reinfection Described at Skilled Nursing Facility

FRIDAY, Feb. 26, 2021 -- Possible reinfection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been observed at a skilled nursing facility...

Rheumatoid Arthritis Meds May Help Fight Severe COVID-19

FRIDAY, Feb. 26, 2021 -- Rheumatoid arthritis drugs may save lives of patients hospitalized with severe cases of COVID-19, according to a groundbreaking...

In Israel, Widespread Vaccination Slashes Severe COVID Cases in Older Patients

FRIDAY, March 26, 2021 -- Israel is among the first nations in the world to have a majority of its citizens vaccinated against the new coronavirus. That effort...

FDA Approves Amondys 45 (casimersen) Injection for the Treatment of Duchenne Muscular Dystrophy (DMD) in Patients Amenable to Skipping Exon 45

CAMBRIDGE, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases,...

FDA Approves Libtayo (cemiplimab-rwlc) Monotherapy for Patients with First-line Advanced Non-Small Cell Lung Cancer with PD-L1 Expression of ≥50%

TARRYTOWN, N.Y. and PARIS, Feb. 22, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug...

Incyte Announces Acceptance and Priority Review of NDA for Ruxolitinib Cream for Atopic Dermatitis

WILMINGTON, Del.--(BUSINESS WIRE) February 19, 2021 -- Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for...

Entresto Granted Expanded Indication in Chronic Heart Failure by FDA

EAST HANOVER, N.J., Feb. 16, 2021 -- Novartis today announced that the US Food and Drug Administration (FDA) has approved the following expanded indication for...

FDA Approves Cosela (trilaciclib) to Decrease the Incidence of Chemotherapy-Induced Myelosuppression

RESEARCH TRIANGLE PARK, N.C., Feb. 12, 2021 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced that...

FDA Approves Evkeeza (evinacumab-dgnb) for Patients with Homozygous Familial Hypercholesterolemia

TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA)...

Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer

COPENHAGEN, Denmark and BOTHELL, Wash.; Feb 10, 2021 – Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced the submission of a...

Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients

ROCKVILLE, Md., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and...

Mirum Pharmaceuticals Announces Completion of Rolling NDA Submission for Maralixibat in Alagille Syndrome

FOSTER CITY, Calif.--(BUSINESS WIRE)--Feb. 1, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced it has completed submission of its rolling New...

Biogen and Eisai Announce FDA’s 3-Month Extension of Review Period for the Biologics License Application for Aducanumab

CAMBRIDGE, Mass. and TOKYO, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and...

Voluntary Withdrawal of Imfinzi Indication in Advanced Bladder Cancer in the US

22 February 2021 -- AstraZeneca today announced the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for previously treated adult patients...

Astellas Announces Positive Topline Results from Two Phase 3 Pivotal Global Trials of Fezolinetant for the Nonhormonal Treatment of Vasomotor Symptoms in Postmenopausal Women

TOKYO, Feb. 19, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced positive topline...

Johnson & Johnson Announces Submission to World Health Organization for Emergency Use Listing of Investigational Single-Shot Janssen COVID-19 Vaccine Candidate

NEW BRUNSWICK, N.J., February 19, 2021– Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for...

Pfizer and BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature to the U.S. FDA

NEW YORK and MAINZ, GERMANY, February 19, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the submission of new data to the...

Novavax Announces Memorandum of Understanding with Gavi for Cumulative Supply to COVAX Facility of 1.1 Billion Doses of COVID-19 Vaccine

GAITHERSBURG, Md., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious...

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